Comparing the Difference in Muscle Synergies Between Healthy Participants and Chronic Stroke Survivors

NCT04155866 | Completed

• 1 other identifier: RIF_Healthy_version 01
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

Participants are seeking to unleash the full therapeutic potential of a newly developed, customizable and potentially commericializable 10-channel Functional Electrical Stimulation (FES) to rehabilitate the gait of chronic stroke survivors. Patricipants will utilize the theory of muscle synergies from motor neurosciences, which are defined as neural modules of motor control that coordinate the spatiotemporal activation patterns of multiple muscles, to guide our personal selections of muscles for FES. Before applying FES stimulations to chronic stroke survivors, participants will have to define normal muscle synergies from age-matched healthy control participants (1 session for each participant). After comparing the difference in muscle synergies in both healthy subjects and chronic stroke survivors, participants are attempting to rehabilitate the gait of chronic stroke survivors by using the wearable. Each chronic stroke survivor will undergo 18-session FES training (\~ 1 month). It is hypothesized that FES will promote motor recovery by supplying the missing normal muscle synergies to chronic stroke survivors at their supposed times of activations in each step cycle during interventional training. It is also expected that the walk synergies of the paretic side of chronic stroke survivors should be more similar to healthy muscle synergies at the two post-training time points than before training. The healthy normal muscle synergies will be defined by EMG recordings from the recruited healthy participants.

Conditions

Healthy

Outcome Measures

Primary Outcomes (5)

• Surface electromyographic signals from up to 14 muscles on each side of healthy participants during gait.

  To assess the muscle synergies, surface EMGs will be recorded from 14 muscles (tibialis anterior (TA), medical gastrocnemius (MG), soleus (SOL), vastus medialis (VM), rectus femoris (RF), hamstrings (HAM), adductor longus (AL), gluteus maximus (GM) lateral gastrocnemius (LG), vastus lateralis (VL), tensor fasciae latae (TFL), erector spinae (ES), external oblique (EO), and latissimus dorsi (LatDor)), using a wireless EMG system (Delsys; 2000 Hz). All electrodes will be securely attached to skin surface using double-sided and medical tapes.

  The assessment will be performed at 1 week

• Surface electromyographic signals from up to 14 muscles on the paretic and non-paretic side during gait.

  To assess the muscle synergies, surface EMGs will be recorded from 14 muscles (tibialis anterior (TA), medical gastrocnemius (MG), soleus (SOL), vastus medialis (VM), rectus femoris (RF), hamstrings (HAM), adductor longus (AL), gluteus maximus (GM) lateral gastrocnemius (LG), vastus lateralis (VL), tensor fasciae latae (TFL), erector spinae (ES), external oblique (EO), and latissimus dorsi (LatDor)), using a wireless EMG system (Delsys; 2000 Hz). All electrodes will be securely attached to skin surface using double-sided and medical tapes.

  The assessment will be performed at baseline

• Surface electromyographic signals from up to 14 muscles on the paretic and non-paretic side during gait.

  To assess the muscle synergies, surface EMGs will be recorded from 14 muscles (tibialis anterior (TA), medical gastrocnemius (MG), soleus (SOL), vastus medialis (VM), rectus femoris (RF), hamstrings (HAM), adductor longus (AL), gluteus maximus (GM) lateral gastrocnemius (LG), vastus lateralis (VL), tensor fasciae latae (TFL), erector spinae (ES), external oblique (EO), and latissimus dorsi (LatDor)), using a wireless EMG system (Delsys; 2000 Hz). All electrodes will be securely attached to skin surface using double-sided and medical tapes.

  The assessment will be performed at 5.5 weeks

• Surface electromyographic signals from up to 14 muscles on the paretic and non-paretic side during gait.

  To assess the muscle synergies, surface EMGs will be recorded from 14 muscles (tibialis anterior (TA), medical gastrocnemius (MG), soleus (SOL), vastus medialis (VM), rectus femoris (RF), hamstrings (HAM), adductor longus (AL), gluteus maximus (GM) lateral gastrocnemius (LG), vastus lateralis (VL), tensor fasciae latae (TFL), erector spinae (ES), external oblique (EO), and latissimus dorsi (LatDor)), using a wireless EMG system (Delsys; 2000 Hz). All electrodes will be securely attached to skin surface using double-sided and medical tapes.

  The assessment will be performed at 2.5 weeks

• Surface electromyographic signals from up to 14 muscles on the paretic and non-paretic side during gait.

  To assess the muscle synergies, surface EMGs will be recorded from 14 muscles (tibialis anterior (TA), medical gastrocnemius (MG), soleus (SOL), vastus medialis (VM), rectus femoris (RF), hamstrings (HAM), adductor longus (AL), gluteus maximus (GM) lateral gastrocnemius (LG), vastus lateralis (VL), tensor fasciae latae (TFL), erector spinae (ES), external oblique (EO), and latissimus dorsi (LatDor)), using a wireless EMG system (Delsys; 2000 Hz). All electrodes will be securely attached to skin surface using double-sided and medical tapes.

  The assessment will be performed at 4 weeks

Secondary Outcomes (13)

• Measuring Gait kinematics from Healthy Participants

  The assessment will be performed at 1 week

• Measuring Gait kinematics from Chronic Stroke Survivors

  The assessment will be performed at baseline

• Measuring Gait kinematics from Chronic Stroke Survivors

  The assessment will be performed at 5.5 weeks

• Measuring Gait kinematics from Chronic Stroke Survivors

  The assessment will be performed at 2.5 weeks

• Measuring Gait kinematics from Chronic Stroke Survivors

  The assessment will be performed at 4 weeks

Study Arms (2)

Healthy participants

Measurement of lower-limb muscle activation from healthy participants.

Other: Measurement of muscle activation.

Chronic Stroke Survivors

Measurement of lower-limb muscle activation from chronic stroke survivors

Other: Measurement of muscle activation.

Interventions

Measurement of muscle activation. OTHER

Measurement of lower-limb muscle activation during walking for healthy participants.

Chronic Stroke Survivors; Healthy participants

Eligibility Criteria

• Age: 40 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Age-matched healthy control subjects will be recruited through advertisements. Chronic Stroke Survivors will be recruited from the local community such as clinic.

You may qualify if:

• For chronic stroke survivors:
• Right-handed elderly chronic stroke survivors; age ≥40; ≥6 months post-stroke
• Unilateral ischemic brain lesions
• Participants should be able to walk continuously for ≥15 min. with or without assistive aid
• For healthy participants:
• Healthy, right-handed subjects, age ≥40, free from any history of major neurological, musculoskeletal, and psychiatric disorders
• Able to walk continuously for ≥20 min. without fatigue.

You may not qualify if:

• For both healthy participants and chronic stroke survivors:
• Cannot comprehend and follow instructions, or with a score \<21 on the mini-mental state exam;
• Have cardiac pacemaker;
• Have skin lesions at the locations where FES or EMG electrodes may be attached;
• Have major depression;
• Present with severe neglect

Sponsors & Collaborators

• Chinese University of Hong Kong: lead
• The Hong Kong Polytechnic University: collaborator
• City University of Hong Kong: collaborator
• Shanghai Jiao Tong University School of Medicine: collaborator

Study Sites (1)

The Hong Kong Polytechnic University

Hong Kong, Hong Kong, 852, Hong Kong

Location

Related Publications (9)

• Krasovsky T, Levin MF. Review: toward a better understanding of coordination in healthy and poststroke gait. Neurorehabil Neural Repair. 2010 Mar-Apr;24(3):213-24. doi: 10.1177/1545968309348509. Epub 2009 Oct 12.

  PMID: 19822722 BACKGROUND

• Peckham PH, Knutson JS. Functional electrical stimulation for neuromuscular applications. Annu Rev Biomed Eng. 2005;7:327-60. doi: 10.1146/annurev.bioeng.6.040803.140103.

  PMID: 16004574 BACKGROUND

• Sheffler LR, Chae J. Neuromuscular electrical stimulation in neurorehabilitation. Muscle Nerve. 2007 May;35(5):562-90. doi: 10.1002/mus.20758.

  PMID: 17299744 BACKGROUND

• Heller BW, Clarke AJ, Good TR, Healey TJ, Nair S, Pratt EJ, Reeves ML, van der Meulen JM, Barker AT. Automated setup of functional electrical stimulation for drop foot using a novel 64 channel prototype stimulator and electrode array: results from a gait-lab based study. Med Eng Phys. 2013 Jan;35(1):74-81. doi: 10.1016/j.medengphy.2012.03.012. Epub 2012 May 4.

  PMID: 22559959 BACKGROUND

• Springer S, Vatine JJ, Wolf A, Laufer Y. The effects of dual-channel functional electrical stimulation on stance phase sagittal kinematics in patients with hemiparesis. J Electromyogr Kinesiol. 2013 Apr;23(2):476-82. doi: 10.1016/j.jelekin.2012.10.017. Epub 2012 Dec 8.

  PMID: 23231828 BACKGROUND

• You G, Liang H, Yan T. Functional electrical stimulation early after stroke improves lower limb motor function and ability in activities of daily living. NeuroRehabilitation. 2014;35(3):381-9. doi: 10.3233/NRE-141129.

  PMID: 25227538 BACKGROUND

• Zhuang C, Marquez J, Qu H, He X, Lan N (2015) A neuromuscular electrical stimulation strategy based on muscle synergy for stroke rehabilitation. 2015:816-819.

  BACKGROUND

• Ferrante S, Chia Bejarano N, Ambrosini E, Nardone A, Turcato AM, Monticone M, Ferrigno G, Pedrocchi A. A Personalized Multi-Channel FES Controller Based on Muscle Synergies to Support Gait Rehabilitation after Stroke. Front Neurosci. 2016 Sep 16;10:425. doi: 10.3389/fnins.2016.00425. eCollection 2016.

  PMID: 27695397 BACKGROUND

• Barroso FO, Torricelli D, Molina-Rueda F, Alguacil-Diego IM, Cano-de-la-Cuerda R, Santos C, Moreno JC, Miangolarra-Page JC, Pons JL. Combining muscle synergies and biomechanical analysis to assess gait in stroke patients. J Biomech. 2017 Oct 3;63:98-103. doi: 10.1016/j.jbiomech.2017.08.006. Epub 2017 Aug 20.

  PMID: 28882330 BACKGROUND

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: October 10, 2019
• First Posted: November 7, 2019
• Study Start: July 1, 2021
• Primary Completion: December 1, 2025
• Study Completion: December 1, 2025
• Last Updated: December 26, 2025

Record last verified: 2025-12

Locations

HK (1)